患者中心主義は、患者をプロトコル開発の中心に置き、多様性・公平性・包括性（DEI）の取り組みを強化することで、臨床試験を変革する最前線にあります。患者の声を積極的に試験デザインと実施に取り入れることで、被験者募集・リテンション、患者の満足度全体が向上し、試験の成功率が向上します。同時に、臨床試験が多様で代表的な患者集団を反映していることを保証することが極めて重要です。SCOPEによる第2回年次「患者中心の試験デザイン・DEI」ストリームでは、患者と施設の意見を初期の計画に真に反映させ、臨床研究の参加者の多様性をグローバルに促進するための新しい革新的なアプローチを深く掘り下げます。「試験デザインとプロトコル開発における患者の声」会議では、革新的なプロトコルデザイン戦略、参加者のフィードバックを統合する効果的な方法、患者の負担を軽減するための新規アプローチについて検討します。「効果的な多様性計画の策定と実行」会議では、多様性計画と申請プロセスに関するFDAの最新の要件を掘り下げ、臨床試験における真の多様性を実現するための障壁を検証し、DEIの実践を強化するための実用的なインサイトを提供します。出席者は、臨床研究における包括性を促進し、代表的な多様性を確保する効果的な戦略を実施する方法について貴重な知識を得ることができます。
2月3日 月曜日
6:30 amGolf Check-In & Breakfast Buffet (Sponsorship Opportunities Available)
8:00 amSCOPE's 4th Annual Masters of Clinical Research Golf Tournament* (Sponsorship Opportunities Available)
Connect with your peers and colleagues at SCOPE's 4th Annual Masters of Clinical Research Golf Tournament. For more information on participating or how you can get involved as a sponsor, please visit the SCOPE Summit website for further details.
*Limited space available. Separate registration and fee required for golf.
9:00 amRegistration Open
12:00 pmGolf Lunch Buffet (Sponsorship Opportunities Available)
PRE-CONFERENCE WORKSHOPS: IN-PERSON ONLY
会議前ワークショップ：対面のみ
12:00 pm- 4:00 pm WORKSHOP: Innovation Day with IQVIA Technologies: Hear the vision. See the products. Join the journey.
INSTRUCTOR:
Ming Shen, Managing Director, Deloitte Consulting LLP
Clinical trial sponsors are invited to join digital product leaders and industry colleagues for an afternoon of discussions, demos, and networking. This interactive event has been carefully curated to help clinical trial professionals crack key challenges across the clinical trial lifecycle: from participant and site user journeys to data security and workflows. Pharmaceutical executives with various roles in clinical operations, innovation, technology, finance/budgeting, data analytics, strategic sourcing, trial managers, medical directors, or patient and site engagement will enjoy an industry panel, interactive roundtables, live demos with product experts, and more! Pre-registration is requested, and IQVIA reserves the right to decline requests that don’t fall within attendee guidelines above: For more details, please contact us.
1:00 pm- 1:45 pm WORKSHOP: Join and Explore ClinEco, SCOPE's B2B Clinical Trial Community and Marketplace
Join this hands-on session with ClinEco, SCOPE’s B2B clinical trial community and marketplace featuring 850+ companies. ClinEco unites sponsors, CROs, service providers, and sites to streamline partnering, vendor research, innovation, and learning. At SCOPE 2024 we introduced the ClinEco Commons, a collaborative space where you can access, visit, and share valuable content as well as contribute to the wealth of knowledge within the SCOPE and ClinEco Community. This year we launch our 'Ask a ClinEco Luminary' program where members can connect directly, and discreetly, with industry leaders and receive insights on a wide range of clinical trial topics. Join now at: clineco.io/register. Open to all SCOPE attendees.
1:00 pm- 2:30 pm WORKSHOP: The Path towards Sustainable Clinical Trials: Reducing the Environmental Impact of Global Clinical Trials
INSTRUCTORS:
Michael J. Cohen, Senior Director, Lead, Environmental Sustainability, PPD/Thermo Fisher Scientific
Thierry Escudier, Portfolio Lead, Pistoia Alliance
Jason Lanier, Environmental Sustainability Focus Area, Director, Janssen Clinical Innovation (JCI)
Diana Steinbuesch, BioX Operations Portfolio Lead (Oncology), Roche
While developing leading and innovative therapies, we must not lose sight of the environmental impacts and greenhouse gas emissions. We can reduce the environmental impact of our studies by prioritizing remote visits and monitoring, by reducing kit wastage, and working together to find ‘greener’ solutions. This workshop will provide a brief overview of research and introductory strategies for reducing emissions as well as a 'Sustainability 101' to help anyone in our industry get started towards developing more environmentally responsible clinical trials. Open to all SCOPE attendees. Sustainable Healthcare Coalition is a Partnering Organization at SCOPE.
1:00 pm- 2:30 pm WORKSHOP: Efficient Importation of Biological Materials into the U.S.
INSTRUCTORS:
Jessica Hammes, Branch Chief, Biological Threat Exclusion, Agriculture Safeguarding and Risk Management, Agriculture Programs and Trade Liaison, Office of Field Operations, U.S. Customs and Border Protection
Jennifer Merriman, Senior Manager, Strategic Biospecimen & Vendor Logistics, Consent, Biospecimens, & Imaging, Global Development Operations, Bristol Myers Squibb Co.
(Additional speakers to be announced.)
U.S. Customs and Border Protection and partner government agencies regulate the importation of biological materials into the United States. The efficient importation of these items can be challenging, as Clinical Trial landscape is ever-evolving. The purpose of this workshop is to discuss current challenges, best practices, and possible solutions to navigate this landscape.
1:00 pm- 2:30 pm WORKSHOP: Sponsor and Site Perspectives: Addressing Current Challenges and Exploring Future Opportunities in Clinical Trial Financing
This workshop will explore sponsor and site perspectives on current challenges and future opportunities in clinical trial financing. It will address complexities in managing trial finance including estimation, budgeting, forecasting, invoicing, payments, reconciliation and others in clinical trial management. The workshop aims to identify innovative solutions to enhance finance management in clinical trials, fostering more accurate projections. Through discussions and interactive sessions, it seeks to provide insights for future opportunities to improve clinical trial finance.
MONDAY AFTERNOON PLENARY SESSION:
月曜日午後のプレナリーセッション：
CONVERGING CLINICAL RESEARCH AND CARE, PATIENT PANEL & PARTICIPANT ENGAGEMENT AWARDS
臨床研究・臨床ケアの融合、患者パネル、参加者エンゲージメント賞
Fast-Forward to 2035: What Success Could Look like in Converging Clinical Research and Care-And How to Get There
Mark McClellan, MD, PhD, Director, Duke-Margolis Institute for Health Policy; Former Commissioner, FDA
On this stage in 2024, we spoke about our mission to converge clinical research and clinical care for the benefit of patients worldwide. We envision a world in which patients participate in research at the point of care as seamlessly as possible. And although we’ve set our vision, and organized the work we are undertaking accordingly, the real fruits of those efforts will not be seen in the short term. We will use this session to talk about where we hope we will be by 2035. What might we reasonably achieve? What does success look like? And what will it take to get there? This session is designed to help us all to raise our gaze beyond the near-term and find inspiration in the future possibilities.
Tips for Getting the Most out of SCOPE
Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco
Visit our FAQ page! We hope this page answers some of your questions related to SCOPE. It consolidates a lot of info for speakers, attendees, and vendors into one page. We look forward to seeing you at SCOPE on February 3-6, 2025, at the Rosen Shingle Creek in Orlando, Florida!
What Do Real Patients Actually Talk About?
Whether at an industry event, a focus group, or another venue, we’ve all heard “real” patients share stories of their conditions, treatment journeys, and lives. But how accurate is what you’ve heard? Are the patients who speak on the podium or in a focus group truly representative of the majority of patients, or do they represent just a small sample? Our panel of patient engagement experts from some of the country’s leading patient advocacy groups and other representative organizations will give the story of what it’s like for most patients to live with illness, including rare and chronic diseases. Join us and learn about the true challenges of disease burden, unmet needs, treatment progression, the challenges-and rewards-of clinical trials, and more.
5:05 pmSCOPE's 9th Annual Participant Engagement Awards Introduction (Sponsorship Opportunity Available)
SCOPE's 9th Annual Participant Engagement Awards
Kelly McKee, Head of Innovative Patient Recruitment, Evinova; Co-Creator of the SCOPE Participant Engagement Award
Now in its 9th year, the Participant Engagement Award (PEA) recognizes innovation and change in how the industry communicates with participants in the fields of recruitment and retention in clinical trials. PEA embodies the values and personal accomplishments of Jerry Matczak, who sadly passed away soon after receiving the inaugural 2017 award. We dedicate this award to Jerry in the hopes that it will serve as a reminder of his ideals and accomplishments. SCOPE’s 2025 Participant Engagement Award program is brought to you by Cambridge Healthtech Institute (CHI)’s SCOPE and is accepting submissions at: https://www.scopesummit.com/participant-engagement-award
5:45 pmSCOPE's Kickoff Reception: A Luau to Remember!
Everyone who’s been to SCOPE knows that the Kickoff Reception is NOT to be missed! This year, we're turning up the tropical vibes with a luau theme.
DRESS CODE: Hawaiian shirts are encouraged! Show off your brightest, boldest, most tropical attire (grass skirts optional!) Let's bring the aloha spirit to life as we kick off another amazing SCOPE conference experience. Join us to reconnect with your old friends, make some new ones, and soak up the Florida sunshine in style!
7:00 pmClose of Day
2月4日 火曜日
6:30 amSCOPE's 5K Rise and Shine Fun Run! (Sponsorship Opportunities Available)
Join SCOPE’s Coordinators on Tuesday, February 4 for our Fun Run! This is an informal event, and ALL abilities are welcome. You can sprint, run, jog, walk, jog-and-talk, or walk-and-talk-the goal is to get up and get moving! Details will be shared closer to the event...remember to pack your sneakers.
7:30 amRegistration Open
7:30 amMorning Coffee (Sponsorship Opportunities Available)
Get Up and Go! Jumpstart your morning with a specialty made-to-order coffee and some delicious treats, courtesy of our sponsors.
-jpg_35ced57f-4e01-4468-86ac-250cb4049821.jpg)
TUESDAY MORNING PLENARY SESSION:
火曜日午前のプレナリーセッション：
REDUCING CYCLE TIMES WITH “IN-HOUSE” CAPABILITIES, DATING GAME WITH PATIENTS & NEW PARADIGM OF PATIENT-LED TRIAL SPONSORS
「インハウス」機能によるサイクルタイムの短縮、患者とのデートゲーム、患者主導の治験依頼者における新たなパラダイム
*Must be present to win.
Exquisite Clinical Trial Delivery in an Ever-Changing World-Evolution and Opportunity for Sustained Performance
Andrew Lee, Senior Vice President & Head, Global Clinical Trial Operations, Merck & Co.
This talk focuses broadly on Merck's strategy to discover, develop, and bring innovative medicines to market by pursuing promising science, prioritizing key opportunities, and adapting to a changing landscape. More specifically, how has Merck decided to optimize clinical trial operations, and the relationships between product development teams, clinical sub-teams, and clinical trial teams? What are key considerations for clinical trial planning, site selection, and protocol design? And, what and why did Merck keep many core capabilities “in-house”?
Beyond the Real-World Data, What Are Patients Saying?
Special LIVE Episode with Studio Audience-Patient Contestants will be Announced Onsite!
SCOPE’s Gameshow Host: Brett Kleger, a man whose dream it was to be a wedding singer or gameshow host
In today’s episode of “The Clinical Trial Dating Game” we have our pharma industry bachelor looking for a volunteer for his trial. He must question and choose from among three patients, who are hidden from view. He has access to all of their data, but there is more to this person than data, so how will he know which questions to ask? How will he avoid bias? How will he recruit on time? Knowing how important patient centricity is to the clinical research industry and with so much on the line, will our bachelor land a date? What could go wrong?
How Patients Can-and Must-Disrupt Traditional Pharma Clinical Trials
Craig Lipset, Founder, Advisor, Clinical Innovation Partners; Co-Chair, Decentralized Trials & Research Alliance (DTRA)
Should biopharma companies be the only "sponsors" for clinical trials of new medicines? Does the current model limit opportunities for unmet needs in small populations or leveraging repurposed drugs? This panel will gather leaders demonstrating ways that patient-led non-profit organizations are challenging assumptions and taking a leadership position in medicine development. No longer can we think of patients as guests at pharma's table-is the next transformation in medicine development going to be entirely patient-led?
9:50 amGrand Opening Coffee & Refreshment Break in the Exhibit Hall (Sponsorships Available) Best of Show Voting Opens
Join us for the Grand Opening Networking Coffee break in our biggest SCOPE Exhibit Hall ever! Mingle with friends, forge new connections, and exchange ideas over your morning cup of joe. Visit exhibitors and learn about their latest and greatest innovations and products...voting opens for our Best of Show awards so don’t forget to vote.
Part 1: Patient Voice in Trial Design and Protocol Development
パート1：試験デザインとプロトコル開発における患者の声
PATIENT VOICE IN PROTOCOL DESIGN
プロトコルデザインにおける患者の声
Can You Hear Me Now? Amplifying the Patient Voice in Trial Design
Peter Schaeffer, Digital & Process Optimization Leader, Digital Analytics & Performance, GSK
Who doesn’t want to feel heard, really? It’s good for our minds and bodies, and when it comes to clinical trials, it’s good science. When patients feel-and are-heard in the early stages of trial design, we set the stage for future success. The session will provide a clear distillation of not only why amplifying the patient voice is worthwhile but also how to do it at a practical level. Our goal is to leave session participants energized and equipped with the confidence and tools to turn up the volume on patient voices in designing their next trials. We will focus on sharing freely available solutions that can support effective partnership and decision-making between patients and participants.
Challenges of Including Patient Voice in EU CTR Materials
EU CTR is making strides in creating harmonization, improving transparency, and increasing the use of patient lay language in materials for participants and their care partners. However, the EU CTR also brings challenges with timelines and getting the global patient voice incorporated in clinical trial materials. This session will explore challenges and impactful solutions for bringing the patient voice into EU CTR patient recruitment materials.
Harnessing Generative AI for Enhanced Protocol Planning: Empowering the Site and Patient Voice
By harnessing Generative AI, AbbVie aims to enhance the protocol planning process by leveraging the power of artificial intelligence to synthesize unstructured data gathered from the insights and perspectives of both sites and patients. This approach elevates the site and patient voice, ensuring that their needs, preferences, and experiences are considered in the development of clinical trial protocols. Furthermore, the presentation will touch on the considerations around clinical trial Diversity Action Plans and how the insights gathered through these core groups can inform the DAPs.
Enhancing Patient Engagement and Recruitment: Leveraging Patient Preferences for Effective Clinical Trials
Alekhya Pochiraju, Senior Product Development Lead, Clinical Operations, Genentech
Effective patient engagement and recruitment are critical for the success of clinical trials. This session will explore strategies to better align clinical trial designs with patient preferences. It will cover approaches to understanding and incorporating patient needs, enhancing communication, and streamlining recruitment processes?ensuring trials are more patient-centric.
Assumptions Are the Root of All Mistakes: Designing Engaging Studies Whilst Avoiding the "Unicorn" Protocol Design
Melissa Harris, Global Head, Patient Recruitment & Engagement, Fortrea
Assumptions in trial design impacts everything. Headways been made with patient-centric design philosophy but ultimately its sites who must execute the study. Listening to and incorporating input from sites and patients concurrently drives new treatments to the right patients, faster. A duel-centric approach is a potent model for achieving efficiency whilst meeting demands of sponsors and patients, beyond simply listening for intelligent, and compassionate protocol measures.
Harnessing Data to Devise Patient-Centric TrialsSpeaker to be Announced, PPD Part of Thermo Fisher Scientific
Clinical trials face significant challenges, with 80% encountering enrollment difficulties and up to 30% of participants withdrawing. By prioritizing patient needs and experiences at every stage-from design to retention-these challenges can be mitigated through strategic use of technology and data. Join our expert panel to explore patient-first models that leverage enhanced data collection, AI insights, and patient-friendly structures, making trials more efficient, accessible, and effective. Discover insights from using services and tools like FSP Feasibility, Integrated Trial Optimization, and Study Gage, designed to optimize trials with a focus on the patient. This session will demonstrate how by applying the right data strategies, one can design truly patient-centered trial experience.
1:35 pmSponsored Networking Luncheon
Take this opportunity to refresh and refuel and network, compliments of SCOPE sponsors! Take a well-deserved break outdoors in the sun, or indoors in the air conditioning.
2:35 pmNetworking Coffee & Dessert Break in the Exhibit Hall
SCOPE’s hall this year is bigger than ever; there’s no way to cover it all in just one break. So, after lunch, grab some dessert and a cup of coffee and visit all those booths that you just couldn’t make it to this morning. Stay to hear our Best of Show Winner announcement and congratulate the winner!
EMBEDDING INCLUSIVE DESIGN INTO GLOBAL DEVELOPMENT
グローバル開発にインクルーシブデザインを組み込む
Diversity Action Plans: Perspectives from CDER-OCE-FDA
Tamy Kim, Director for Regulatory Affairs and Policy, Oncology Center for Excellence (OCE), FDA
The FDA's Diversity Action Plan guidance sets expectations for advancing diversity in clinical trial populations so that clinical trial data are representative to the U.S. population. In this session, get insights into the agency's expectations, and discuss strategies for meeting these standards. Attendees will gain a deeper understanding of how to align their trials with regulatory guidance to ensure representativeness in clinical research.
Diversity Action Planning: From Study Design to Site Execution
Learn how to embed inclusive design and planning capabilities in global clinical development to increase the likelihood of success at sites. Understand what sites really need from global sponsors to increase the number of underrepresented participants in their studies. Hear about the mechanics of enrollment monitoring between global, US site engagement and site teams to drive continuous improvements.
Optimizing Usability is Optimizing Data Quality-Elevating CNS Endpoint Data through Patient and Site-Centric Solutions
Holly Robertson, PhD, Head of Advisory Services, Professional Services, Medidata, a Dassault Systemes Co.
CNS trials present unique challenges for patients and study staff, including raters, due to complicated diagnostic criteria often involving subjective reporting and clinical judgment. These factors can lead to variability in outcomes, prompting the need for additional safeguards to ensure reliable endpoint data. However, such measures can introduce operational burdens that impact the patient and site experience, potentially negatively affecting patient enrollment, study timelines, and the ultimate success of the trial. In this session, we will explore a tech-enabled, science-driven approach to eCOA design and delivery that addresses the complexities inherent in CNS clinical trials, resulting in improved operational efficiency. Learn how this joint approach optimizes solution usability to achieve high-quality endpoint data for clinical trials and an improved experience for patients and sites.
Protocol Simplification Championship: Where Innovation Meets Simplification, Collaboration, and Recognition
Tuba Bas, PhD, Senior Director, Clinical Center of Excellence, Bristol Myers Squibb Co.
In this session, BMS shares its Protocol Simplification Championship (PSC) designed to encourage protocol simplification through an innovative competition and recognition program. Research has shown competition can spur creativity and motivate teams. Further, recognition programs contribute to a sense of purpose and fulfillment among employees. PSC is built upon these principles and represents a novel, unique approach to simplifying protocols, allowing collaboration, celebrating innovation, and building a culture of recognition.
AI-Powered Patient Recruitment & RWD
Wout Brusselaers, CEO, Deep 6 AI
In this presentation, learn how AI can be applied to both structured and unstructured clinical data in order to access real-time data from an ecosystem of health systems across the country, query sites' EMR data for precision patient matching, and collaborate with IRB-approved site researchers via a shared platform.
What Women Want: Actionable Insights to Grow Enrollment for Your Next Trial from Research with Over 3,500 Diverse Women
Megan Preovolos, Director, Patient Recruitment, Bus Dev, Everyday Health Group
Give us 15 minutes, and we’ll give you 3,500 patient voices. The Everyday Health Group Pregnancy & Parenting team reveals highlights from their new study on what attracts women to join clinical trials and what keeps them engaged. The study includes insights from women 18 - 45, with more than 40% identifying as women of color. Learn why Gen Z is so unique, how to craft nuanced messaging that improves recruitment and the unique concerns and preferences of key cohorts.
5:55 pmWelcome Reception in the Exhibit Hall (Sponsorship Opportunities Available)
Wind down at the end of a busy session day with colleagues and old and new friends. Networking is always in full swing at this reception, so raise a glass with your favorite exhibitors and take a chance at winning one of our fabulous raffle prizes (must be present to win). Continue your networking over dinner at one of the Rosen Shingle Creek's fine dining or casual restaurants and eliminate the need to face Orlando traffic.
7:15 pmClose of Day
7:15 pmEvening Courtesy Shuttles to Pointe Orlando (Sponsorship Opportunities Available)
The Pointe Orlando is an open air-entertainment destination, featuring local and brand names restaurants, bars, nightclubs, 20-screen movie theater, comedy club and family attractions.
Shuttles will run a continuous loop from 7:00pm-11:00pm (last pick up 30 minutes before end time) between Rosen Shingle Creek, Rosen Plaza, Residence Inn Orlando and Pointe Orlando.
On-site look for our courtesy shuttle signage directing you to pick up locations within the hotels.
2月5日 水曜日
7:45 amRegistration Open
BREAKFAST PRESENTATIONS
朝食プレゼンテーション
BREAKFAST PRESENTATION OPTION #2:Expanding the Patient Universe: Transforming Clinical Trials through Inclusive, Data-Driven DesignChristopher Riley, Director, Strategic Insights, Solutions, H1
In today’s complex clinical research landscape, achieving patient-centricity and inclusivity is more critical than ever. This presentation introduces Patient Universe, a groundbreaking solution designed to optimize trial feasibility while addressing health equity challenges. Attendees will learn how leveraging real-world health equity data can transform patient recruitment strategies, create inclusive trial designs, and improve participant engagement. Through actionable insights and use cases, this session will demonstrate how advanced analytics and innovative technologies can bridge gaps in representation, support diversity action planning and enhance trial outcomes.
BREAKFAST PRESENTATION OPTION #3:Scaling Success: How Sanofi and Trialbee Drive Patient-centric Recruitment and Reduce Site Burden in Global Asthma Programs
Join Whitley Albright (Sanofi) and Gaynor Anders (Trialbee) to discuss how to keep patients at the center of focus while reducing site burden in a complex global asthma program by: connecting patients to the right trials with targeted outreach and a highly efficient global process; pre-qualifying all patients with live medical secondary screening to reduce the volume sent to sites, improve trust, and increase referral-to-consent ratio; keeping disqualified patients ready to enroll with program-level rematching; centralizing activity in a Patient Recruitment Platform (PRP) to manage progress, evaluate site performance, and measure campaign ROI; building a collaborative, supportive, and meaningful relationship.
Learn how these organizations are scaling recruitment success globally while achieving diversity and inclusion goals, reducing site burden, and keeping patients at the center of care.
8:45 amTransition to Sessions
THE FUTURE OF PROTOCOL DESIGN: DIGITALIZATION AND SIMPLIFICATION
プロトコルデザインの将来：デジタル化とシンプル化
Going with the (Digital Data) Flow: Reduce Time & Effort on Study Start-Up
Donald Jennings, Senior Advisor of Systems, Tech@Lilly Clinical Design and Operations, Eli Lilly and Company
Clinical study start-up work can be…tedious. We know. It’s chock full of highly manual processes to configure systems and tools with inconsistently specified inputs and data, for starters. Add to that the nature of today’s protocols and processes, which typically result in limited ability to reliably sync updates from a single source of truth. These manual approaches don’t just stifle efficiency; they limit innovation. The net result is a hindrance to progress in speeding study start-up and-ultimately-the delivery of new medicines to patients. The Digital Data Flow (DDF) initiative aims to address these challenges by moving the study start-up process from one of manual asset creation to a fully automated, dynamic approach. Join us to understand how DDF enables this via the foundational Unified Study Definitions Model, developed by CDISC in partnership with TransCelerate.
This, Not That: Data Collection, Optimized
Laura Galuchie, Senior Director, TransCelerate Program Lead, Oversight Committee, Merck
This session provides an update on a collaborative research study looking at optimizing the collection of non-core and extraneous clinical research data collection practices, with the aim to reduce patient and site burden. The session will explore considerations that helped define the study methodology and initial study findings from a sample of protocols. Speakers will also discuss implications of early study findings and potential strategies to optimize protocol data collection.
Designing and Operationalizing Double-Blind RCTs with Sham Controls in Digital Therapeutics
Gazal Vakili, Director, Digital Health Innovation, Sumitomo Pharma
This presentation delves into the intricate design and operationalization of double-blind randomized controlled trials (RCTs) featuring sham controls within the realm of digital therapeutics. By exploring best practices for trial design, participant engagement, and data integrity, we will discuss the critical elements that ensure robust and reliable outcomes. Attendees will gain insights into the unique challenges and innovative solutions in conducting RCTs in digital health, paving the way for more effective and evidence-based therapeutic interventions.
Putting Patients at the Heart of Research: Transforming Trials through Inclusive Design
Akiko Shimamura, Senior Vice President, Trial Design & Optimization, TriNetX, LLC
As industry leaders and healthcare organizations seek to enhance the relevance and impact of their research, they face the dual challenge of designing studies that are scientifically rigorous and genuinely representative.
Explore how inclusive trial design empowers diverse patient populations and advances research outcomes. Akiko Shimamura, SVP of Trial Design & Optimization at TriNetX, shares strategies to integrate patient perspectives into protocol design, overcoming barriers to patient participation, and leveraging real-world data to enhance inclusivity in trial cohorts. Learn actionable frameworks for equitable, technology-driven, patient-centric research that enhances the relevance and impact of clinical studies, putting the patient at the heart of every study.
10:25 amCoffee Break in the Exhibit Hall
SCOPE is ALL about networking-with clients, colleagues, sponsors and exhibitors. Take this chance to visit booths you haven't been to, build new relationships, and fuel up with coffee for the rest of the busy day ahead. Last chance to vote for the Best of Show award! Make your vote count!
10:45 amSpecial Book Signing
Fundamentals of Decentralized Clinical Trials
Editors: Isaac R. Rodriguez-Chavez & Anna Yang
Location: Gatlin Foyer, ClinEco Booth #4
DRIVING THE CHARGE: DIVERSITY LEADERS SHARE HOW THEY ARE CHAMPIONING THE IMPERATIVE OF INCLUSIVE TRIALS
推進力：多様性リーダーがインクルーシブ試験の必要性をどのように推進しているかを共有
Diversity in Clinical Trials: The Homework and the Homeruns
Bianca Green, Lead, Diversity & Inclusion in Clinical Trials, Takeda
Join a panel of industry leaders who are spearheading initiatives to break down barriers in recruiting racially, ethnically, and socioeconomically diverse populations. Hear case study examples of initiatives they have implemented-learn what has worked and gain lessons from what has not. Engage in open discussions, exchange innovative ideas, and collaborate with peers to develop actionable steps that advance Diversity, Equity, and Inclusion in clinical trials. You will not want to miss this opportunity to gain real-world advice from the true innovators in this space.
Monique Adams, PhD, MS, Executive Director, Global Head Diversity & Inclusion in Clinical Trials, Sanofi
Leave Nothing to Chance: A Strategic Guide to Inclusive Clinical Trial Enrollment
Neil Weisman, President, Continuum Clinical
Many organizations have yet to implement a corporate DEI strategy that effectively informs Clin Ops on how to approach developing a Diversity Action Plan. This session will provide practical strategies for those who do not have an established DEI framework and are charged with improving engagement and enrollment of trial participants in underrepresented communities. You’ll leave with actionable insights to drive meaningful, inclusive progress in clinical research.
12:55 pmSponsored Networking Luncheon
Once again, join us for lunch, courtesy of our generous sponsors.
1:55 pmNetworking Coffee & Dessert Break in the Exhibit Hall-Best of Show Winner Announced
SCOPE's Networking Coffee and Dessert Break is the perfect time to pick up a sweet treat, courtesy of our sponsors, and fuel up for the afternoon with a cup of coffee or soft drink. Visit our Game Card Sponsors to fill your Game Card with stickers and get in a little more networking time before afternoon sessions!
-jpg_3fef6f50-a8ff-4613-b844-9dd3fd020160.jpg)
WEDNESDAY AFTERNOON PLENARY SESSION:
水曜日午後のプレナリーセッション：
FOSTERING INNOVATION IN PHARMA R&D, LEVERAGING DIGITAL TOOLS WITHOUT LOSING YOUR MIND & UNLEASHING GenAI FOR TRIALS
製薬R&Dにおけるイノベーションの促進、デジタルツールの活用、試験向けGenAIの活用
Fostering Clinical Innovation in a Large Pharmaceutical Organization
April Lewis, Head, Innovative Health, Global Development, Johnson & Johnson Innovative Medicine
This presentation explores strategies for fostering innovation within a large pharmaceutical organization by focusing on four key areas: developing a clear mandate and compelling vision to guide innovation efforts; designing and engineering an infrastructure that supports creativity and collaboration; building a high-performance, diverse team empowered to drive innovation; and seeking opportunities for true patient-centricity and sponsor-agnostic innovation. By aligning these elements, the organization can create a sustainable innovation ecosystem that prioritizes patient outcomes and drives transformative breakthroughs in healthcare.
How Can Sponsors Leverage Increasing Technology Capabilities with Quality
Angela DeLuca, Associate Vice President, Global Study Operations, Amgen
Sponsors can leverage increasing technology capabilities to enhance quality by integrating advanced data analytics, AI, and automation into their drug development and manufacturing processes. These technologies enable real-time monitoring, predictive analytics, and streamlined workflows, ensuring higher precision and consistency in product quality. Additionally, digital tools facilitate better compliance with regulatory standards and more efficient management of clinical trials, ultimately accelerating time-to-market while maintaining rigorous quality standards.
3:25 pmChairperson's Introduction (Sponsorship Opportunity Available)
The Unleashing of Gen AI: Revolutionizing Healthcare and Beyond
Disa Lee Choun, Head of Integrated Clinical and Operational Analytics (ICOA), Johnson & Johnson
Gen AI, a groundbreaking approach that seamlessly merges artificial intelligence into our daily lives, holds immense potential for transforming the pharmaceutical and healthcare industries. This paradigm shift not only demands a thorough understanding of the ethical implications, potential biases, and social consequences of AI systems- it also requires a steadfast focus on creating tangible value that benefits individuals and society at-large. By harnessing advanced AI technologies, Gen AI can pave the way for unparalleled breakthroughs, elevating patient care, enabling personalized medicine, streamlining processes, and revolutionizing the way we approach healthcare as a whole. Join the debate on the real value-based use cases and explore the endless possibilities that Gen AI brings to the table.
4:00 pmBooth Crawl & Refreshment Break in the Exhibit Hall (Sponsorships Available) Last Chance for Exhibit Viewing
We know you're tired, we know the Exhibit Hall is huge, and we know you still have some booths to visit, some connections to make, some networking to do. SCOPE's Networking Booth Crawl is the time to do it! Crawl if you must, but be sure to visit our sponsored booths for some food, drinks, and enough energy to finish SCOPE strong! Our final Networking Exhibit Hall break is the final time to see the exhibits you haven't seen and meet the people you haven't yet met. The break ends with another amazing raffle prize, so be sure to get your Game Cards in and the lucky winner (must be present to win) could be you!
5:00 pmClose of Day
5:00 pmEvening Courtesy Shuttles to Pointe Orlando (Sponsorship Opportunities Available)
The Pointe Orlando is an open air-entertainment destination, featuring local and brand names restaurants, bars, nightclubs, 20-screen movie theater, comedy club and family attractions.
Shuttles will run a continuous loop from 5:00pm-9:00pm (last pick up 30 minutes before end time) between Rosen Shingle Creek, Rosen Plaza, Residence Inn Orlando and Pointe Orlando.
On-site look for our courtesy shuttle signage directing you to pick up locations within the hotels.
2月6日 木曜日
7:15 amRegistration Open
BREAKFAST PRESENTATION
朝食プレゼンテーション
7:45 amSponsored Presentation (Opportunity Available)
8:15 amTransition to Sessions
Part 2: Developing and Executing Effective Diversity Plans
パート2：効果的な多様性計画の策定と実行
DIVERSITY ACTION PLANS: EXPECTATION, DEVELOPMENT, IMPLEMENTATION, AND FEEDBACK
多様性アクションプラン：期待、開発、実施、フィードバック
Actionable Strategies to Promote Diversity in Clinical Research Participation
Katie Shaw, Senior Director Patient Recruitment & Enablement, Global Patient and Site Services, IQVIA
This topic gets a lot of airtime; rightfully so. But airtime doesn’t equal progress. Progress comes most quickly when we exchange learnings freely. This panel will share findings based on efforts in diversifying clinical research participation, including insights from TransCelerate sponsor interviews. The goal? To help us all make more progress more quickly in diversifying clinical research participation.
Talk Title to be Announced
Supplementing Patient Burden Assessments with Patient-Centric Learnings to Drive Operational Excellence
Incorporating patient perspective into protocol design is vital for patient-centric trials. We will describe an automated patient burden assessment framework that we use to quantify patient burden in trials. However, specific patient populations experience burden differently. We will discuss approaches for incorporating such differences and recommend mitigation strategies aimed at reducing the negative impacts on patient experience and operational outcomes.
Being Intentional About Diversity in Clinical Trials: Real-World Results
Tamara Oyejide, Senior Director of Patient Recruitment, Apnimed
You've heard the reasons as to why diversity in clinical trials is so important. You may have even received "tips and tricks" to increase diversity in your own clinical trials. In this session we invite you to sit back, relax, and listen to real-world examples of how two Phase 3 clinical trials met or exceeded the CDC national averages while recruiting key patient populations. Listen, Learn, and Execute!
Challenges of Diversity Data in Clinical Trials: Bridging Gaps for Inclusive Research
Michel Reid, Senior Director & Head, Global Demographics & Diversity, GSK
Diversity in clinical trial data is crucial, yet cultural differences in health behaviors, communication styles, and varying values on research participation create barriers. Historical data lacks representation, and limited infrastructure in certain regions further hinders inclusivity. Without diverse participation, we risk missing important insights and correlations. Expanding access and investing in outreach to diverse populations are essential steps to bridging these gaps for more inclusive and accurate research outcomes.
11:10 amNetworking Coffee Break
INTEGRATING CLINICAL RESEARCH INTO CLINICAL CARE
臨床研究を臨床ケアに統合
Taking Research to the People: Decentralized Trials, Leveraging Technology to Enable Community-Based Approaches
Amy Yarker, Senior Business Development Manager, Life Sciences Partnership & Growth, NIHR Clinical Research Network
This session will explore the transformative power of decentralized clinical trials, taking research beyond traditional hospital clinics to reach participants in social care settings and underserved communities. Discover how cutting-edge technology and innovating methods are breaking down barriers, improving accessibility, and generating valuable real-world evidence. From mobile research units to patients’ homes, learn how decentralized trials are bringing research directly to people.
Talk Title to be AnnouncedIntegrating Community Health Solutions: A Case Study
Shelly Barnes, Global Clinical Innovations and Digital Lead, UCB
Is it operationally feasible to develop a clinical research plan that incorporates community-based health entities or solutions? The FDA has indeed advocated for the inclusion of community health providers in clinical trials. However, challenges remain, particularly when major community solution providers face difficulties in establishing a favorable cost model. Also, is there substantial evidence indicating that investigators or community health providers are willing to participate in this new clinical trial execution model? This UCB case study aims to examine the advantages, disadvantages, and potential challenges of integrating community health solutions into clinical trials.
1:25 pmTransition to Lunch
LUNCHEON PRESENTATION: Rethinking Trial Design with Real-World Data
Kwame Marfo, Senior Director, Product Strategy, Clinical Development, Komodo Health
Discover how Komodo’s innovative no-code solution, MapView with MapAi, is reshaping the way clinical development teams understand and address the diverse healthcare journeys of patients from different racial and ethnic backgrounds. Komodo’s presentation will explore how streamlined data insights can uncover disparities, enhance trial inclusivity, and optimize patient representation, empowering teams to design more equitable and effective clinical trials.
2:00 pmSCOPE Summit 2025 Adjourns
* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。
アジェンダ・講演者・スポンサー更新
2025年 プログラム
◆
Sunday Golf, Kick-Off Keynote & Participant Engagement Award
月曜のゴルフ、キックオフ基調講演、参加者エンゲージメント賞
◆SCOPE’s Kickoff Reception
SCOPEによるキックオフレセプション
◆
Patient Voice in Trial Design and Protocol Development
試験デザインとプロトコル開発における患者の声
◆
Developing and Executing Effective Diversity Plans
効果的な多様性計画の策定と実行
◆
Enrollment Planning and Patient Recruitment
登録計画・被験者募集
◆
Patient Engagement and Retention through Communities and Technology
コミュニティ・技術による被験者エンゲージメントとリテンション
◆
Clinical Trial Forecasting, Budgeting and Contracting
臨床試験の予測・予算編成・契約
◆
Resource Management and Capacity Planning for Clinical Trials
臨床試験のリソース管理・キャパシティプランニング
◆
Mastering an Outsourcing Strategy
アウトソーシング戦略のマスター
◆
Relationship and Alliance Management in Outsourced Clinical Trials
臨床試験アウトソーシングにおける関係と提携管理
◆
Modernizing Lab, Biomarker & Data Management Operations
ラボ・バイオマーカー・データ管理業務の近代化
◆
Biomarker & Biospecimen Technology & Innovation
バイオマーカー・バイオ試料の技術とイノベーション
◆
Data Technology for End-to-End Clinical Supply Management
E2Eの臨床サプライ管理向けデータ技術
◆
Clinical Supply Chain Strategies to Align Process, Products and Patients
臨床サプライチェーン戦略でプロセス・製品・被験者を連携
◆
Clinical Trial Venture, Innovation & Partnering *
臨床試験のベンチャー・イノベーション・提携 *
*Separate Registration Required
